1. Technical Field
This invention relates to a medical device and, in particular, an introducer and a method for retaining and releasing an expandable, intraluminal prosthesis for the endovascular repair of a diseased or damaged vessel.
2. Related Art
Throughout this specification the terms proximal and proximally are used for a position or direction towards the patient's heart and the terms distal and distally are used for a position or direction away from the patient's heart.
The deployment of intraluminal prostheses into the lumen of a patient from a remote location by the use of a deployment device or introducer has been disclosed in a number of earlier patents and patent applications. U.S. Pat. No. 4,562,596 entitled “Aortic Graft, Device and Method for Performing an Intraluminal Abdominal Aortic Aneurysm Repair”, which is incorporated herein by reference, proposes the retention of a self-expanding graft within a sleeve until it is to be deployed, at which time the sleeve is withdrawn and the graft is allowed to expand. U.S. Pat. No. 4,665,918 entitled “Prosthesis System and Method”, which is incorporated herein by reference, proposes a system and method for the deployment of a prosthesis in a blood vessel. The prosthesis is positioned between a delivery catheter and an outer sheath and expands outwardly upon removal of the sheath.
U.S. Pat. No. 4,950,227 entitled “Stent Delivery System”, which is incorporated herein by reference, proposes the delivery of a stent by mounting the stent to the outside of an inflatable catheter and retaining the ends of the unexpanded stent by fitting a sleeve over either end of the stent. Expansion of the stent is caused by inflation of the catheter between the sleeves so that the ends of the stent are withdrawn from the respective sleeves and the stent released and expanded into position.
U.S. Pat. No. 5,387,235 entitled “Expandable Transluminal Graft Prosthesis for Repair of Aneurysm”, which is incorporated herein by reference, discloses apparatus and methods of retaining grafts onto deployment devices. These features and other features disclosed in U.S. Pat. No. 5,387,235 could be used with the present invention.
U.S. Pat. No. 5,720,776 entitled “Barb and Expandable Transluminal Graft Prosthesis for Repair of Aneurysm”, which is incorporated herein by reference, discloses improved barbs with various forms of mechanical attachment to a stent. These features and other features disclosed in U.S. Pat. No. 5,720,776 could be used with the present invention.
U.S. Pat. No. 6,206,931 entitled “Graft Prosthesis Materials” discloses graft prosthesis materials and a method for implanting, transplanting replacing and repairing a part of a patient and particularly the manufacture and use of a purified, collagen based matrix structure removed from a submucosa tissue source. These features and other features disclosed in U.S. Pat. No. 6,206,931 could be used with the present invention, and the disclosure of U.S. Pat. No. 6,206,931 is incorporated herein by reference.
PCT Patent Publication Number No. WO99/29262 entitled “Endoluminal Aortic Stents” discloses a fenestrated prosthesis for placement where there are intersecting arteries. This feature and other features disclosed in PCT Patent Publication Number No. WO99/29262 could be used with the present invention, and the disclosure of PCT Patent Publication Number No. WO99/29262 is incorporated herein by reference.
PCT Patent Publication Number No. WO03/034948 entitled “Prostheses for Curved Lumens” discloses prostheses with arrangements for bending the prosthesis for placement into curved lumens. This feature and other features disclosed in PCT Patent Publication Number No. WO03/034948 could be used with the present invention, and the disclosure of PCT Patent Publication Number No. WO03/034948 is incorporated herein by reference.
U.S. Utility patent application Ser. No. 10/447,406 entitled “Trigger Wire System” discloses release wire systems for the release of stent grafts retained on introducer devices. This feature and other features disclosed in U.S. Utility patent application Ser. No. 10/447,406 could be used with the present invention, and the disclosure of U.S. Utility patent application Ser. No. 10/447,406 is incorporated herein by reference.
U.S. Utility patent application Ser. No. 10/609,846 entitled “Thoracic Aortic Stent Graft Deployment Device” discloses introducer devices adapted for deployment of stent grafts particularly in the thoracic arch. This feature and other features disclosed in U.S. Utility patent application Ser. No. 10/609,846 could be used with the present invention, and the disclosure of U.S. Utility patent application Ser. No. 10/609,846 is incorporated herein by reference.
U.S. Utility patent application Ser. No. 10/602,930 entitled “Stent-Graft Fastening” discloses arrangements for fastening stents onto grafts particularly for exposed stents. This feature and other features disclosed in U.S. Utility patent application Ser. No. 10/602,930 could be used with the present invention, and the disclosure of U.S. Utility patent application Ser. No. 10/602,930 is incorporated herein by reference.
PCT Patent Publication Number No. WO03/053287 entitled “Stent Graft with Improved Graft Adhesion” discloses arrangements on stent grafts for enhancing the adhesion of such stent grafts into walls of vessels in which they are deployed. This feature and other features disclosed in PCT Patent Publication Number No. WO03/053287 could be used with the present invention, and the disclosure of PCT Patent Publication Number No. WO03/053287 is incorporated herein by reference.
PCT Patent Publication Number No. WO98/53761 entitled “A Prosthesis and a Method and Means of Deploying a Prosthesis”, which is incorporated herein by reference, discloses various embodiments of an introducer for positioning an expandable endovascular prosthesis in a lumen of a patient.
Some prosthetic devices may have shorter bare wire stents or bare wire stents that comprise thinner wire. Smaller wire diameter causes the stent to have a lower radial force while in a hollow retention device, and allow more free space for stent struts to move relative to each other. This lower radial force and increased free movement of the stent struts may allow barbs as well as stent eyelets to catch adjacent stent struts and become entangled. It may be desirable to provide a method and apparatus to deploy a graft prosthesis that provides a controlled release of a proximal bare wire stent of the prosthesis that decreases the likelihood of entanglement.
A control mechanism, such as a trigger wire, may prevent a graft prosthesis having a proximal bare wire stent from being released prematurely from a proximal retention device of an introducer. Many introducers utilize a single connection point to retain the graft prosthesis in the retention device. This single-point connection may allow the bare wire stent of the graft prosthesis to rotate within the retention device, which could cause the struts of a bare wire stent to tangle. It may be desirable to keep the bare wire stent from rotating within the retention device to lessen the likelihood of entanglement.